QA Operation Intern at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

InternshipExperience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Degree in CTF, Pharmacy, Chemistry, Biology or similar scientific degrees
Knowledge of pharmaceutical production and production control
Knowledge of GMP/FDA regulations
English language proficiency
Ability to work in a team
Organizational skills
Excellent relational skills

Responsibilities

Support the QP and Quality Operations Manager in product batch release by verifying certificates of analysis, collecting and analyzing batch records, and checking deviations and change controls
Ensure proper archiving of batch record documentation according to company standards and procedures
Perform preliminary evaluation of deviation and complaint events, assign initial criticality level, and assess need for escalation to management
Review investigation plans, support investigators in identifying root causes and corrective/preventive actions
Conduct full review of deviation and complaint investigations (e.g., supporting materials, quality impact on batches/areas, regulatory and compliance impact)
Participate in periodic client meetings, provide email support on quality queries, notify clients of deviations and complaints per QTA, and ensure closure in Trackwise
Prepare client-specific KPIs and participate in on-site client visits
Actively participate in audit preparation and support presentation of relevant topics during audits
Ensure completion of assigned training
Ensure continuous update of SOPs in area of competence by drafting necessary documentation in compliance with GMP requirements
Contribute to achieving Zero Past Due, RFT, and OTD objectives in area of competence
Approve preventive and corrective actions and effectiveness verification records

Skills

GMP

FDA

Batch Record Review

Deviation Investigation

Root Cause Analysis

CAPA

Quality Control

Certificate of Analysis

Change Control

Client Communication

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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